Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447545
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-24
Brief Title:
Comparison Between Low Pressure Pneumoperitoneum With High Pressure Pneumoperitoneum in Post-operative Pain Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy
Sponsor:
Gulab Devi Hospital
Organization:
Gulab Devi Hospital
Study Overview
Official Title:
Comparison Between Low Pressure Pneumoperitoneum With High Pressure Pneumoperitoneum in Post-operative Pain Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of pain and common bile duct injuries in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum versus high pressure pneumoperitoneum
Detailed Description:
Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder It helps people when gallstones cause inflammation pain or infection Since the early 1990s the laparoscopic cholecystectomy technique has largely supplanted the open approach for routine gallbladder removal This method is recommended for various conditions such as cholecystitis both acute and chronic symptomatic cholelithiasis biliary dyskinesia acalculous cholecystitis gallstone pancreatitis and gallbladder massespolyps-similar to the indications for an open cholecystectomy Gallbladder cancers however are typically better addressed through open cholecystectomy In the United States around 20 million people have gallstones leading to approximately 300000 cholecystectomies annually Ten to fifteen percent of the population has asymptomatic gallstones and among them 20 experience symptoms such as biliary colic Complications including acute cholecystitis gallstone pancreatitis choledocholithiasis and gallstone ileus manifest in approximately 1 to 4 of symptomatic cases Gallstone prevalence increases with age with women between 50 to 65 years having a 20 incidence compared to 5 in men Cholesterol constitutes 75 of gallstones while the remaining 25 are pigmented however clinical signs and symptoms remain consistent regardless of the gallstone composition1 Low-pressure and high-pressure pneumoperitoneum both integral to laparoscopic cholecystectomy have been subjects of extensive research primarily focusing on their impact on post-operative pain management
Traditionally in laparoscopic cholecystectomy one of the initial procedures involves creating pneumoperitoneum This is done by introducing carbon dioxide CO2 either through a veress needle or a port in the abdominal wall The CO2 is then gently infused into the peritoneal cavity reaching a pressure of 10-20 mmHg at a rate of 4-6 litres per minute To maintain the pneumoperitoneum a steady gas flow of 200-400 mlmin is sustained In conventional laparoscopic cholecystectomy a higher intra-abdominal pressure of 12-15mmHg is used while low-pressure pneumoperitoneum laparoscopic cholecystectomy employs pressures below 8mmHg2 High-pressure pneumoperitoneum involving insufflation pressures typically ranging from 12 to 15 mmHg or higher facilitates enhanced intraoperative visualization ease of surgical manipulation and shorter operative times However despite these advantages it commonly correlates with increased post-operative pain and discomfort particularly in the form of referred shoulder pain The mechanism behind this pain is attributed to diaphragmatic irritation and irritation of the phrenic nerve due to the increased pressure within the peritoneal cavity3 In contrast low-pressure pneumoperitoneum characterized by lower insufflation pressures often ranging from 8 to 12 mmHg aims to mitigate the post-operative discomfort experienced by patients Studies exploring the use of lower pressures have indicated promising outcomes in reducing post-operative pain levels shoulder discomfort and overall patient discomfort following laparoscopic cholecystectomy4 Although low-pressure pneumoperitoneum may potentially prolong the operative duration due to decreased visibility and the need for more delicate surgical manoeuvres it presents a viable option for patients prone to experiencing heightened post-operative pain The advantages of decreased pain reduced shoulder discomfort and potentially faster recovery post-surgery make low-pressure pneumoperitoneum an appealing consideration especially for patients with a lower threshold for pain or those with a history of difficulties in managing post-operative discomfort According to recent study pain was experienced in 225 in Low pressure vs 57 in high pressure pneumoperitoneum technique 56
Bile duct injury BDI following cholecystectomy particularly laparoscopic cholecystectomy LC is indeed a serious complication associated with significant morbidity and mortality The incidence of BDI has increased with the adoption of laparoscopic techniques The complications often result from anatomical misperceptions or inadvertent dissection leading to injury to the common bile duct CBD Several factors contribute to the increased incidence of BDI in LC compared to open cholecystectomy These include disorientation of anatomical variables inadvertent dissection at Calots triangle or visual misperception by the operating surgeon Proximal injuries occurring within 2cm from the bifurcation are becoming more prevalent Recognition of CBD injury is crucial for prompt and effective management as delayed diagnosis can lead to severe complications such as systemic inflammatory response syndrome and multi-organ failure syndrome The time of presentation of these injuries can vary making early detection challenging Preventing common bile duct injury involves several key principles
1 Optimal Exposure of Calots Triangle Proper exposure of Calots triangle allows the surgeon to visualize the anatomical structures clearly reducing the risk of inadvertent injury
2 Judicious Use of Diathermy Near CBD Territory Careful use of diathermy electrosurgery near the CBD is essential to avoid thermal injury Excessive use of diathermy can lead to tissue damage and increase the risk of bile duct injury
3 Use of a 30-Degree Telescope A 30-degree laparoscope provides a better angle of vision enhancing the surgeons ability to visualize anatomical structures accurately during laparoscopic procedures
4 Safe Clip Application without Tenting of CBD Applying clips to secure structures without tenting the CBD helps avoid compression and potential injury Proper clip placement is crucial for securing structures while minimizing the risk of damage to nearby tissues
5 Adherence to the Rule of Thumb Surgeons should be mindful of the rule of thumb to prevent common bile duct injury This involves meticulous and precise surgical technique including gentle tissue handling and avoiding excessive traction on the structures
In conclusion preventing common bile duct injury during cholecystectomy requires a combination of technical skill anatomical knowledge and adherence to established principles Surgeons must be vigilant and adopt a cautious approach to minimize the risk of this serious complication Early recognition and active management of CBD injuries are essential for improving patient outcomes and reducing morbidity and mortality associated with this iatrogenic catastrophe7
The choice between these techniques involves a careful consideration of multiple factors including the specific characteristics of the patient the surgeons expertise and the complexities of the surgical procedure As medical practitioners continue to explore ways to enhance patient outcomes and minimize post-operative discomfort the debate between low-pressure and high-pressure pneumoperitoneum in laparoscopic cholecystectomy remains an active area of research and clinical consideration
Traditionally in laparoscopic cholecystectomy one of the initial procedures involves creating pneumoperitoneum This is done by introducing carbon dioxide CO2 either through a veress needle or a port in the abdominal wall The CO2 is then gently infused into the peritoneal cavity reaching a pressure of 10-20 mmHg at a rate of 4-6 litres per minute To maintain the pneumoperitoneum a steady gas flow of 200-400 mlmin is sustained In conventional laparoscopic cholecystectomy a higher intra-abdominal pressure of 12-15mmHg is used while low-pressure pneumoperitoneum laparoscopic cholecystectomy employs pressures below 8mmHg2 High-pressure pneumoperitoneum involving insufflation pressures typically ranging from 12 to 15 mmHg or higher facilitates enhanced intraoperative visualization ease of surgical manipulation and shorter operative times However despite these advantages it commonly correlates with increased post-operative pain and discomfort particularly in the form of referred shoulder pain The mechanism behind this pain is attributed to diaphragmatic irritation and irritation of the phrenic nerve due to the increased pressure within the peritoneal cavity3 In contrast low-pressure pneumoperitoneum characterized by lower insufflation pressures often ranging from 8 to 12 mmHg aims to mitigate the post-operative discomfort experienced by patients Studies exploring the use of lower pressures have indicated promising outcomes in reducing post-operative pain levels shoulder discomfort and overall patient discomfort following laparoscopic cholecystectomy4 Although low-pressure pneumoperitoneum may potentially prolong the operative duration due to decreased visibility and the need for more delicate surgical manoeuvres it presents a viable option for patients prone to experiencing heightened post-operative pain The advantages of decreased pain reduced shoulder discomfort and potentially faster recovery post-surgery make low-pressure pneumoperitoneum an appealing consideration especially for patients with a lower threshold for pain or those with a history of difficulties in managing post-operative discomfort According to recent study pain was experienced in 225 in Low pressure vs 57 in high pressure pneumoperitoneum technique 56
Bile duct injury BDI following cholecystectomy particularly laparoscopic cholecystectomy LC is indeed a serious complication associated with significant morbidity and mortality The incidence of BDI has increased with the adoption of laparoscopic techniques The complications often result from anatomical misperceptions or inadvertent dissection leading to injury to the common bile duct CBD Several factors contribute to the increased incidence of BDI in LC compared to open cholecystectomy These include disorientation of anatomical variables inadvertent dissection at Calots triangle or visual misperception by the operating surgeon Proximal injuries occurring within 2cm from the bifurcation are becoming more prevalent Recognition of CBD injury is crucial for prompt and effective management as delayed diagnosis can lead to severe complications such as systemic inflammatory response syndrome and multi-organ failure syndrome The time of presentation of these injuries can vary making early detection challenging Preventing common bile duct injury involves several key principles
1 Optimal Exposure of Calots Triangle Proper exposure of Calots triangle allows the surgeon to visualize the anatomical structures clearly reducing the risk of inadvertent injury
2 Judicious Use of Diathermy Near CBD Territory Careful use of diathermy electrosurgery near the CBD is essential to avoid thermal injury Excessive use of diathermy can lead to tissue damage and increase the risk of bile duct injury
3 Use of a 30-Degree Telescope A 30-degree laparoscope provides a better angle of vision enhancing the surgeons ability to visualize anatomical structures accurately during laparoscopic procedures
4 Safe Clip Application without Tenting of CBD Applying clips to secure structures without tenting the CBD helps avoid compression and potential injury Proper clip placement is crucial for securing structures while minimizing the risk of damage to nearby tissues
5 Adherence to the Rule of Thumb Surgeons should be mindful of the rule of thumb to prevent common bile duct injury This involves meticulous and precise surgical technique including gentle tissue handling and avoiding excessive traction on the structures
In conclusion preventing common bile duct injury during cholecystectomy requires a combination of technical skill anatomical knowledge and adherence to established principles Surgeons must be vigilant and adopt a cautious approach to minimize the risk of this serious complication Early recognition and active management of CBD injuries are essential for improving patient outcomes and reducing morbidity and mortality associated with this iatrogenic catastrophe7
The choice between these techniques involves a careful consideration of multiple factors including the specific characteristics of the patient the surgeons expertise and the complexities of the surgical procedure As medical practitioners continue to explore ways to enhance patient outcomes and minimize post-operative discomfort the debate between low-pressure and high-pressure pneumoperitoneum in laparoscopic cholecystectomy remains an active area of research and clinical consideration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None